Aa
questions to ask regarding the consent form
I am so glad I stumbled upon this site. I have been reading peoples experiences since I first discovered the site and they have been very helpful. As I had posted earlier I am in the process of deciding/researching a clinical trial with either bocep or telep. Liver biopsy(0-3 in three years) mild elevated liver enzymes and VL 199,000. I am wondering if there are some suggested questions to ask that I might and probably will miss as I read through a consent form ( I am supposed to be getting one via email soon). Any advice would be helpful.
It is very encouraging to me that so many peole have had a positive response, and I am very grateful for those of you who continue to provide support even though you are finished. (thanks Bill). I hope some day I can offer someone helpful support. I will post as anything intersting comes up.
It is very encouraging to me that so many peole have had a positive response, and I am very grateful for those of you who continue to provide support even though you are finished. (thanks Bill). I hope some day I can offer someone helpful support. I will post as anything intersting comes up.
If there was any evidence that Telaprevir caused heart attacks, the trials would have been stopped as they were for the first PI. I forgot the name of it.
Don't be frightened by the consent form. It must list all events that took place during the trial. The vast majority are not related to the drug. Telaprevir does have side effects, but the benefit of the drug is less time taking Interferon and Ribaviron. Any day without those two is a great day.
Best of luck to you.
Eric
Don't be frightened by the consent form. It must list all events that took place during the trial. The vast majority are not related to the drug. Telaprevir does have side effects, but the benefit of the drug is less time taking Interferon and Ribaviron. Any day without those two is a great day.
Best of luck to you.
Eric
I did the telaprevir study and a few things come to mind. if the PCR's are blinded then make sure to do your own at least 4 & 12 week test. You can ask your primary doc for the PCR lab order. These results may come in handy later in TX to help make crucial decisions.
As for the consent form, none of it is negotible. You sign it as written or walk. The trial nurse went over it in person with me before starting TX. They keep asking if you understand everything. It kinda of scares you when you read through it. My trial was a phase III so there had been a few people that had heart attacks, kindey failure, and even death. But they always say they can not prove it was the meds. Yea right.
Anyway try and not read into it to much. The new drugs are worth it and does help the odds to attaining SVR. Best of luck
As for the consent form, none of it is negotible. You sign it as written or walk. The trial nurse went over it in person with me before starting TX. They keep asking if you understand everything. It kinda of scares you when you read through it. My trial was a phase III so there had been a few people that had heart attacks, kindey failure, and even death. But they always say they can not prove it was the meds. Yea right.
Anyway try and not read into it to much. The new drugs are worth it and does help the odds to attaining SVR. Best of luck
If there is a possibility you may get a placebo, I suggest having a back up plan in place.
When my bloods started to tank at week 7 they reduced my peg. I immediately contacted another hepatologist and explained my situation....being in a trial and facing dose reductions. I arranged a "plan B" so that if the trial docs made me either skip meds or reduce doses further, I was going to leave the trial and continue SOC uninterrupted on my own. My trial center knew from the beginning that I wanted to be aggressive because I was very candid about my stance from the beginning.
It turned out that I didn't need to leave my trial thankfully. Hgb and anc stabilized and I was back on full peg in no time. I am now almost 6 months post and still UND.
I would just hate to see anyone in a situation where they are getting a placebo and forced to reduce their SOC drugs...especially the riba.
Also, ask if they offer a roll-over for anyone getting the placebo that later relapses.
Good luck to you. Please keep us posted.
Isobella
When my bloods started to tank at week 7 they reduced my peg. I immediately contacted another hepatologist and explained my situation....being in a trial and facing dose reductions. I arranged a "plan B" so that if the trial docs made me either skip meds or reduce doses further, I was going to leave the trial and continue SOC uninterrupted on my own. My trial center knew from the beginning that I wanted to be aggressive because I was very candid about my stance from the beginning.
It turned out that I didn't need to leave my trial thankfully. Hgb and anc stabilized and I was back on full peg in no time. I am now almost 6 months post and still UND.
I would just hate to see anyone in a situation where they are getting a placebo and forced to reduce their SOC drugs...especially the riba.
Also, ask if they offer a roll-over for anyone getting the placebo that later relapses.
Good luck to you. Please keep us posted.
Isobella
Andiamo has hit on all of the important points. The language of mine referred to Procrit at the doctor's discretion, not by name, but as a drug that may be helpful if hemoglobin drops. They did provide it along with the trial meds. It also mentioned filgrastim, also not by name, but as a drug that could be useful to treat low neutrophils. It did NOT mention doctor's discretion, but indicated that it would be permissible to use it during the trial. My insurance covered it.
The consent form is mostly a way to prevent patients from suing the providers. They inform you of all the known side effecgts and then some.
I think the questions for anyone participating in the trial:
Will the trial provide rescue drugs such as Procrit for example?
Is the trial blinded?
What is the probability of getting a placebo?
How many arms of the trial are there and what are the dosing levels in each arm?
What rules are there for continuing and criteria for dropping out?.
I think the questions for anyone participating in the trial:
Will the trial provide rescue drugs such as Procrit for example?
Is the trial blinded?
What is the probability of getting a placebo?
How many arms of the trial are there and what are the dosing levels in each arm?
What rules are there for continuing and criteria for dropping out?.
Have an Answer?
You are reading content posted in the Hepatitis C Community
Learn about this treatable virus.
Getting tested for this viral infection.
3 key steps to getting on treatment.
4 steps to getting on therapy.
What you need to know about Hep C drugs.
How the drugs might affect you.
These tips may up your chances of a cure.
A list of national and international resources and hotlines to help connect you to needed health and medical services.
Herpes sores blister, then burst, scab and heal.
Herpes spreads by oral, vaginal and anal sex.
STIs are the most common cause of genital sores.
Condoms are the most effective way to prevent HIV and STDs.
PrEP is used by people with high risk to prevent HIV infection.
